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ProSolv® CardioVascular is intended for use by doctors and non-physicians (e.g., sonographers, technicians, nurses) who are affiliated with medical labs that use images obtained from digital-imaging DICOM instruments (echo, vascular, nuclear cardiology, cardiac catheterization, MRI, etc.) The ProSolv® CardioVascular image management and reporting system is software that operates on standard PC equipment using Windows 95 or later operating system. ProSolv® CardioVascular provides the functionality for archiving, viewing, measuring, analyzing, and reporting digital studies generated by digital-imaging instruments from a multitude of manufacturers. The software is available in several configurations: Administrator (report viewing, edit patient demographic information), Viewer (image and report viewing, basic measurements), and Analyzer (Viewer features plus measurements, qualitative assessment, and report creation and design). The software can be used in a variety of network configurations ranging from a stand-alone workstation to a network of workstations connected through TCP/IP networking to a ProSolv® DICOM Server. The DICOM Server permits studies to be transferred from DICOM compatible imaging instruments directly to a ProSolv® database using TCP/IP.

The ProSolv® CardioVascular software operates on a PC computer using the Windows 95 or later operating system. ProSolv® CardioVascular Viewer allows the user to view medical images acquired from digital-imaging instruments, track examinations and patient data with a database, and view reports. The software can display DICOM images and most non-DICOM images. ProSolv® CardioVascular Analyzer includes all the functionality of the Viewer plus routine and stress echo regional wall motion analysis, qualitative and quantitative image evaluation, report generation, and customizable reports, measurements, and comment lists. Each of the products can be packaged with the optional ProSolv® CardioVascular Server capability to allow remote database access over a network.

The provided document, a 510(k) summary for ProSolv® CardioVascular, does not contain information about specific acceptance criteria or a detailed study designed to prove the device meets such criteria. Instead, it focuses on demonstrating substantial equivalence to a predicate device.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

Not provided in the document. The submission is a 510(k) for substantial equivalence, not a performance study with explicit acceptance criteria.

2. Sample Size Used for the Test Set and Data Provenance:

Not applicable or not provided. This document describes a software system for image management and reporting, not an AI or diagnostic device that would typically undergo a test set evaluation for performance metrics like sensitivity or specificity. There's no mention of a "test set" in the context of clinical data.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

Not applicable or not provided. As there's no mention of a test set with performance metrics requiring ground truth, expert involvement in this capacity is not discussed.

4. Adjudication Method for the Test Set:

Not applicable or not provided.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No, an MRMC comparative effectiveness study was not done. The document does not describe any human reader studies, with or without AI assistance. The device is a software system for managing and analyzing medical images, not an AI for diagnosing or assisting human readers in a comparative effectiveness setting.

6. Standalone (Algorithm Only) Performance Study:

No, a standalone performance study was not done in the context of reporting specific performance metrics like sensitivity, specificity, or accuracy for an algorithm. The device itself is a standalone software product, but the submission focuses on its functionalities, safety, and equivalence to a predicate, not on algorithmic performance against a defined ground truth.

7. Type of Ground Truth Used:

Not applicable or not provided. The submission focuses on the functionality of the software (archiving, viewing, measuring, analyzing, reporting) and its ability to handle DICOM and non-DICOM images. There's no mention of a specific ground truth (like pathology, expert consensus, or outcomes data) against which the device's analytical outputs were directly evaluated for accuracy. The "measurements" and "analysis" functions are presumably based on established medical formulas and protocols rather than a novel AI algorithm requiring ground truth validation.

8. Sample Size for the Training Set:

Not applicable or not provided. This device is a PACS component/image management system, not described as using machine learning or AI that would require a "training set" in the conventional sense.

9. How the Ground Truth for the Training Set Was Established:

Not applicable or not provided.

Summary of Acceptance Criteria and Study Approach from the Document:

The acceptance criteria and study approach in this 510(k) submission are based on the demonstration of substantial equivalence to a predicate device (ProSolv® Echo products), rather than formal performance testing against explicit acceptance criteria.

• Acceptance Criteria (Implicit): The device is considered acceptable if its safety and effectiveness are not adversely affected by the expanded indications for use and added features compared to the predicate device. The core program is "basically the same," and differences "do not adversely affect the safety or effectiveness."
• Study: The "study" here is primarily a comparison and analysis of features and functionalities between the ProSolv® CardioVascular and the predicate ProSolv® Echo products.
  • The document highlights that the image viewer was already a generic DICOM viewer and few changes were made to it.
  • The primary changes were the addition of new measurements and reports for expanded medical disciplines (vascular, nuclear cardiology, cardiac catheterization, MRI).
  • The "beta site" mention implies some level of user feedback or validation for the vascular measurements and reports, but no formal study data from this beta site is presented regarding quantitative acceptance criteria.
  • The flexibility and customizability of the software are presented as contributing to effectiveness without compromising safety.
• Conclusion: The submission concludes that ProSolv® CardioVascular is substantially equivalent to ProSolv® Echo, meaning it meets the regulatory requirements for market clearance based on this comparison.

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